Virology Core Laboratory

Introduction

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDShas a requirement for the operation of the Virology Core Laboratory.  The current Virology Core Laboratory (VCL) is held by Duke University (HHSN272201800003C).

Description

The primary purpose of the VCL is to quantitatively measure viral RNA levels in samples in support of a candidate AIDS vaccine (or other intervention) being tested.  The VCL will also produce a large volume of at least 500ml, well characterized SIV, SHIV, and/or HIV viral stocks that will serve as standard reagents for the scientific community.    Assays may be performed on fresh and/or frozen preclinical samples.  All assays undergo testing for inter- and intra-assay as well as inter- and intra-operator variability.  Standard operating procedures (SOPs) are developed for all assays, laboratory processes, and equipment use and maintenance.   Additionally, all work done by the VCL is conducted under good laboratory practice (GLP)-like standards, thereby ensuring rigor and reproducibility.  For the purposes of this contract, GLP-like standards are defined as the application of the principles of Good Laboratory Practices Regulation, codified in CFR Title 21 Part 58, but not requiring external accreditation or official Food and Drug Administration (FDA) regulatory review of the laboratory. 

The Contractor shall develop, acquire, optimize, and conduct assays to characterize and quantitatively determine the level of SIV, SHIV, or HIV viral RNA in samples such as plasma, mucosal tissues or secretions, lymphoid tissues, or other tissues derived from animals infected with SIV, SHIV, or HIV and in samples from in vitro virus cultures and virus stocks.  In vivo studies are anticipated to largely include NHP animal studies but may extend to small animal models including mouse models or others as directed by the COR.  Assays to detect viral RNA for other infectious agents may be requested.

The Contractor shall use current state-of-the-art technologies to conduct quantitative and high-throughput viral RNA assays, shall incorporate new and optimized technologies for assay development into contract activities when appropriate, and shall conduct other activities to accomplish the technical objectives of the statement of work (e.g. virus stock production).  Assays shall incorporate appropriate positive and negative controls using reference panels to define background and dynamic range and shall demonstrate reproducibility and consistency.

Specifically, the Contractor shall: 1) conduct validated viral assays using GLP-like processes; 2) receive, store, catalog, track, and maintain an inventory of the samples for evaluation; 3) analyze, manage, report, and deposit assay data; 4) perform project management activities related to contract activities; 5) conduct initial and final transition activities, as needed; and 6) perform Option work described below, if required.

It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded.  The period of performance will be for one (1) year (Base Period) plus six (6) one year Options (terms that may be exercised by the Government unilaterally), for a total possible performance period of 7 years, beginning on or about November 15, 2024.  The performance requirement will be the delivery of 3.0 full time equivalents (FTEs) per year for the base period (Year 1) and Option periods 1-6 (Year 2 through Year 7).  Please note that the number of FTEs is exclusive of subcontractor and consultant effort. 

In addition, the Government may exercise Options to accommodate unanticipated increases in demand as follows:

Options 7 through 13: Increased Level of Effort:  The Government may exercise Options for increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of the contract. Should the Government elect to exercise these Options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.5 Full Time Equivalent (FTE) for each Option exercised.  These Options may be exercised once per year during Years 1 through 7.  The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or Option year in which the Option is exercised.  Please note that the number of FTEs is exclusive of subcontractor and consultant effort. 

Any responsible Offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about September 7, 2023, and may be accessed through SAM.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."